PLATE-BENDING PRESS 329.30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-10 for PLATE-BENDING PRESS 329.30 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2020-01191
• MDR Report Key: 9812063
• Report Source: HEALTH PROFESSIONAL,OTHER
• Date Received: 2020-03-10
• Date of Report: 2020-02-11
• Date Mfgr Received: 2020-03-18
• Device Manufacturer Date: 2012-05-04
• Date Added to Maude: 2020-03-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARA DITTY-BOVARD
• Manufacturer Street: 1302 WRIGHTS LANE EAST
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6103142063
• Manufacturer G1: WERK H
• Manufacturer Street: IM BIFANG 6
• Manufacturer City: HAEGENDORF 4614
• Manufacturer Country: SZ
• Manufacturer Postal Code: 4614
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PLATE-BENDING PRESS
• Generic Name: INSTRUMENT, BENDING OR CONTOURING
• Product Code: HXP
• Date Received: 2020-03-10
• Returned To Mfg: 2020-02-18
• Model Number: 329.30
• Catalog Number: 329.30
• Lot Number: 7826102
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
• Manufacturer Address: 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-10